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fda sheet

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msds (material safety sheet)

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Synthesis Reference

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Molecular Weight

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Melting Point

204 - 205oC

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H2O Solubility

Soluble

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State

Solid

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LogP

0.455

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Dosage Forms

Powder for solution

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Indication

For the treatment of Koposi's sarcome connected to AIDS.

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Pharmacology

Doxorubicin is an antineoplastic in the anthracycline class. General properties of drugs in this class include: interaction with DNA in a variety of different ways including intercalation (squeezing between the base pairs), DNA strand breakage and inhibition with the enzyme topoisomerase II. Most of these compounds have been isolated from natural sources and antibiotics. However, they lack the specificity of the antimicrobial antibiotics and thus produce significant toxicity. The anthracyclines are among the most important antitumor drugs available. Doxorubicin is widely used for the treatment of several solid tumors while daunorubicin and idarubicin are used exclusively for the treatment of leukemia. Doxorubicin may also inhibit polymerase activity, affect regulation of gene expression, and produce free radical damage to DNA. Doxorubicin possesses an antitumor effect against a wide spectrum of tumors, either grafted or spontaneous. The anthracyclines are cell cycle-nonspecific.

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Absorption

No information avaliable

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side effects and Toxicity

LD50=21800 ug/kg (rat, subcutaneous)

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Patient Information

Patients and their caregivers should be informed of the expected adverse effects of
DOXIL® , particularly hand-foot syndrome, stomatitis, and neutropenia and related complications of
neutropenic fever, infection, and sepsis.

Hand-Foot Syndrome (HFS): Patients who experience tingling or burning, redness, flaking,
bothersome swelling, small blisters, or small sores on the palms of their hands or soles of their feet (symptoms of
Hand-Foot Syndrome) should notify their physician.

Stomatitis: Patients who experience painful redness, swelling, or sores in the mouth (symptoms
of stomatitis) should notify their physician.

Fever and Neutropenia Patients who develop a fever of 100.5°F or higher should notify their
physician.

Nausea, vomiting, tiredness, weakness, rash, or mild hair loss Patients who develop any of
these symptoms should notify their physician.

Following its administration, DOXIL® may impart a reddish orange color to the urine and
other body fluids. This nontoxic reaction is due to the color of the product and will dissipate as the drug is
eliminated from the body.